September 2018 FDA Recall Sparklefresh by Medline Industries Inc
D-0247-2019 - Microbial Contamination of Non-Sterile Product

This Class II drug recall was voluntarily initiated by Medline Industries Inc on September 17, 2018 for the product Sparklefresh. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0247-2019

Reason for Recall
Microbial Contamination of Non-Sterile Product
Initiated
09-17-2018
Reported
11-14-2018
Quantity
994,756 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81381
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Medline Industries Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-04-2020
Product Description About Product Description
Full technical description of the product.
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA

Batch or Lot Expiration Information

Lot# a) Lot 102920C, exp 10/29/2020 and 111220C, exp 11/11/2020; b) 111620D, exp 11/16/2020; c) 111420D, exp 11/14/2020; d) 111720C, exp 11/17/2020

Affected Packages Involved in this Recall

53329-083-21 Sparklefresh Flouride Toothpaste
53329-083-92 Sparklefresh Flouride Toothpaste
53329-083-93 Sparklefresh Flouride Toothpaste
53329-083-94 Sparklefresh Flouride Toothpaste